Gima PREGNANCY TEST User guide

PROFESSIONAL MEDICAL PRODUCTS

TEST RAPIDO DI GRAVIDANZA ULTRA MIDSTREAM HCG (URINA)
ULTRA HCG PREGNANCY RAPID TEST MIDSTREAM (URINE)
TEST RAPIDE DE GROSSESSE ULTRA MIDSTREAM HCG (URINE)
PRUEBA DE EMBARAZO RÁPIDA ULTRA MIDSTREAM HCG (ORINA)
TESTE RÁPIDO DE GRAVIDEZ ULTRA MIDSTREAM HCG (URINA)

ΓΡΉΓΟΡΟ ΤΕΣΤ ΕΓΚΥΜΟΣΥΝΉΣ ULTRA MIDSTREAM HCG (ΟΥΡΊΑ)

ULTRA HCG SCHWANGERSCHAFTSSCHNELLTEST - MIDSTREAM

SZYBKI TEST CIĄŻOWY ULTRA HCG TYPU MIDSTREAM (MOCZ)

M29103-M-Rev.4-03.21

29103

Gima S.p.A.

Via Marconi, 1 - 20060 Gessate (MI) Italy
[e-mail] - [e-mail]

www.gimaitaly.com

Made in China

2°C

30°C

0197

ENGLISH

PRINCIPLE

Ultra HCG Pregnancy Rapid Test Midstream is a rapid, one-step lateral ow immunoassay in midstream format for the

qualitative detection of human chorinic gonadotropin (hCG) in urine to aid in the detection of pregnancy. The test utilizes
a combination of antibodies including a monoclonal hCG antibody to selectively detect elevated level of hCG. The assay
is conducted by adding urine to the hydrophil stick and obtaining the result from the colored lines.

PRECAUTIONS

Please read all the information in this package insert before preforming the test.

- Do not use after the expiration date printed on the foil pouch.

- Store in a dry place at 2-30°C or 35.6-86°F. Do not freeze.

- Do not use if pouch is torn or damaged.

- Keep out of the reach of children.

- For in vitro diagnostic use. Not to be taken internally.

- Do not open the test foil pouch until you are ready to start the test.

- The used test should be discarded according to local regulations.

KIT CONTENT:

- Test midstream - Package insert

MATERIALS REQUIRED BUT NOT PROVIDED

- Timer - Specimen Collection Container

INSTRUCTIONS

1. Remove the midstream from the foil pouch and test it immediately in one hour

2. Take down the cap of the midstream, hold the midstream so as to place the absorbent tip in the urine stream or place
the absorbent tip (≥2/3) in urine in a clean cup for at least 15 seconds.

3. Cover the cap on the testing midstream, then lay down the product on a clean and stable desk, start the timer immediately.

4.

Read the result at 3 minutes; don’t interpret the result after 10 minutes.

Positive

Or

Negative

Urine

4

Invalid

READING THE RESULTS

POSITIVE: Two distinct colored lines appear. One line should be in the Control Window (C) and another line should

be in the Test Window (T).
One line may be lighter then the other; they do not have to match. This means you are probably pregnant.
NEGATIVE: One colored line appears into the Control Window (C). No line appears in the Test Window (T), This means

that you are probably not pregnant.

INVALID: The result is invalid if no colored line appears in the Control Window (C), even if a line appears in the Test
Window (T). You should repeat the test with a new midstream test.

LIMITATIONS

There is the possibility that this test midstream may produce false results. Consult your physician before making any
medical decisions.

1. Drugs which contain hCG (such as Pregnyl, Profasi, Pergonal, APL) can give a false positive result. Alcohol, oral
contraceptives, painkillers, antibiotics or hormone therapies that do not contain hCG should not affect the test result.

2. Very dilute urine specimens, as indicated by a low specic gravity, may not contain representative levels of hCG. If
pregnancy is still suspected, a rst morning urine specimen should be collected 48 hours later and tested.

3. Very low levels of hCG (less than 50mIU/ml) are present in urine specimens shortly after implantation. However,
because a signicant number of rst trimester pregnancies terminate for natural reasons1,a test result that is weakly
positive should be conrmed by retesting with a rst morning urine specimen collected 48 hours later.

4. This test may produce false positive results. A number of conditions other than pregnancy, including trophoblastic
disease and certain non-trophoblastic neoplasms including breast cancer, and lung cancer, cause elevated levels of

2,3

hCG

. Therefore, the presence of hCG in urine should not be used to diagnose pregnancy unless these conditions

have been ruled out.

5

ENGLISH

5. This test may produce false negative results. False negative results may occur when the levels of hCG are below

the sensitivity level of the test. When pregnancy is still suspected, a rst morning urine specimen should be collected

48 hours later and tested. In case pregnancy is suspected and the test continues to produce negative results, see a
physician for further diagnosis.

6. This test provides a presumptive diagnosis for pregnancy. A conrmed pregnancy diagnosis should only be made by
a physician after all clinical and laboratory ndings have been evaluated.

QUESTIONS & ANSWERS

1. How does the test work?

The Test detects a hormone in your urine that your body produces during pregnancy (hCG - human chorionic
gonadotropin). The amount of pregnancy hormone increases as pregnancy progresses.

2. How soon after I suspect that I am pregnant can I take the test?

You can test your urine as early as the rst day you miss your period. You can perform the test anytime of the day; however,
if you are pregnant, rst morning urine contains the most pregnancy ormone.

3. Do I have to test with rst morning urine?

Althought you can test at any time of the day, your rst morning urine is usually the most concentrated of the day and

would have the most hCG in it.

4. How accurate is the test?

A clinical evalutation was conducted comparing the results obtained using the Test to another commercially available urine

hCG test. The consumer clinical trial included 608 urine specimens: both assays identied 231 positive and 377 negative

results. The results demonstrated > 99.0% overall accuracy of the Test when compared to the other urine hCG test.

5. How sensitive is the test?

The test detects hCG in urine at a concentration of 10 mIU/mL or greater. The test has been standardized to the W.H.O.
Third International Standard. The addition of LH (300 mIU/mL), FSH (1,000 mIU/mL), and TSH (1,000 µIU/mL) to negative
(0 mIU/mLm hCG) and positive (10 mIU/mL hCG ) specimens showed no cross-reactivity.

6. What should I do if the result shows that I am pregnant?

It means that your urine contains hCG and you are probably pregnant. See your doctor to conrm that you are pregnant

and to discuss the steps you should take.

7. How do I know that the test was run properly?

The appearance of a colored line in the control window (C) tells you that you followed the test procedure properly and
the proper amount of urine was absorbed.

8. What should I do if the result shows that I am pregnant?

It means that no hCG has been detected in your urine and probably you are not pregnant. If you do not start your period
within a week of its due date, repeat the test with a new midstream test. If you receive the same result after repeating
the test and you still do not get your period, you should see your doctor.

BIBLIOGRAPHY

1. Steier JA, P Bergsjo, OL Myking Human chorionic gonadotropin in maternal plasma afterinduced abortion, spontaneous abortion and
removed ectopic pregnancy, Obstet. Gynecol.1984; 64(3): 391-394;

2. Dawood MY, BB Saxena, R Landesman Human chorionic gonadotropin and its subunits inhydatidiform mole and choriocarcinoma,

Obstet. Gynecol. 1977; 50(2): 172-181;

3. Braunstein GD, JL Vaitukaitis, PP Carbone, GT Ross “Ectopicproduction of human chorionic gonadotropin by neoplasms”, Ann. Intern

Med. 1973; 78(1): 39-45

Index of Symbols

Caution: read instructions
(warnings) carefully

Manufacturer Temperature limit

Keep away from sunlight Keep in a cool, dry place Expiration date

Product code Lot number

In vitro diagnostic medical device
complies with Directive 98/79 / EC

Consult instructions for use

Contains sufcient

for “n” tests

Disposable device,
do not re-use

Don’t use if package

is damaged

In vitro diagnostic
medical device